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Increasing Risk Management Prowess As much art as science

by Paul Armstrong PE, LSSBB CMQ/OE

Risk management is increasingly the responsibility of quality managers. The typical approaches to implementing and managing risk is based on objectively categorization of events based on rigorous predictions of severity, probability and, in FMEA, detection. This rational categorical approach provides consistency and a basis for organizational decision-making. However, this purely objective consideration of events as high or low risk does not include a key element that underscores all risk management. That key element is that risk only exists as it is assumed and understood by people. It is not a purely objective set of threat vectors. As stated by Deming, management is prediction, and that is particularly true for risk management. Deming also showed how profound knowledge is equally parts objective and subjective. Applying that to risk management reveals a need to combine the objective calculation of consequence and probability with the psychological factors such as fear of losing and des

  • Filetype: pptx
  • Publish date: 2014-10
  • Keywords:Risk, Risk management
Open Access

How to Apply Risk to your Quality Management System:

Defining and Building a Risk Management Strategy for Quality and Compliance Management Systems

by Tom Barlow, EtQ, Inc.

This session will explore the strategy behind risk in compliance; define the various ways and terms associated with risk; and discuss how business processes are incorporating risk throughout the enterprise, driving a proactive approach to continuous improvement. We will specifically address how risk is shaping compliance within industries today, and illustrate where risk can be applied to ensure the highest level of quality and compliance, including: • Risk in Design: We will explore the concept of incorporating risk-based methods into the design phase of the product lifecycle. Through the use of risk-based tools (FMEA, Hazard Analysis, etc.) organizations can identify potential risks early in design, reduce the number of in-field failures, and take a proactive approach to risk mitigation. • Risk in Process: We will examine the benefits of incorporating risk into the many post-market processes that affect quality and compliance. Most significantly, we will look at how risk assessment u

  • Filetype: pdf
  • Publish date: 2014-10
  • Keywords:QMS, Risk, Risk Management
Open Access

How Delightful is your Audit Program?

The next step in the evolution of your audit program...

Learn why your internal audit program should be an integral part of how your organization sustains positive results and how to make that happen if it is not. The 4 evolutionary stages of audit program development will be discussed in detail as this session teaches attendees how to develop an internal audit program from one that is backward facing, reactionary and solely compliance based to one that is also forward seeking, continuous improvement driving and results sustaining. The Kano model of customer satisfaction will be used as the framework to explore this new 21st century audit paradigm, as we move through the four phases of audit program evolution. These phases are 1) compliance seeking, 2) compliance maintenance, 3) risk managing and continuously improving and 4) achieving delightful results. We will also discuss who will be the auditor of the future, and what skills they will need.

  • Filetype: pdf
  • Publish date: 2014-10
  • Keywords:Audit, Kano Model, VOC, Risk Management, Improvement

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